Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023.
GSK has said it will not be able to move ahead with regulatory filings for otilimab as a treatment for rheumatoid arthritis (RA), after it failed to show the desired level of efficacy in tw
Johnson & Johnson has secured another regulatory approval for its BCMAxCD3 bispecific antibody for multiple myeloma – Tecvayli – adding to the wide range of therapies available for the
Less than a week before Ipsen's palovarotene was due to go in front of an FDA advisory committee, the meeting has been called off following a request by the regulator for more data.
AstraZeneca's lengthy and turbulent development of CTLA4 inhibitor tremelimumab has at least led to a regulatory approval as part of a combination therapy for advanced liver cancer.
Bristol-Myers Squibb is going after a second indication for its first-to-market cardiac myosin inhibitor Camzyos, a drug tipped to be a future blockbuster and the top prospect in the compan